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July 2, 2007 -- The FDA today approved the first generic versions of
prescription Lamisil tablets to treat nail fungus infection and a generic
version of Lamisil cream to be sold as an over-the-counter athlete's foot
treatment.

Lamisil is terbinafine hydrochloride. Its patent expired on June 30,
2007.

The FDA approved applications from multiple generic drugmakers for generic
versions of Lamisil tablets in 250-milligram formulations as a treatment for
nail fungus. Such infections occur when fungi invade a fingernail or toenail,
or the skin underneath the nail.

Lamisil tablets are usually taken for six to 12 weeks for nail infections.
Lamisil is not appropriate for people with liver and kidney disease. Patients
may be asked to get lab tests during that time to rule out rare liver and blood
side effects. More common side effects may include headache, diarrhea, and
upset stomach.

The FDA also approved an application for a generic version of
over-the-counter Lamisil cream (terbinafine hydrochloride, 1%) to treat
athlete's foot, a skin disease caused by a fungus that usually occurs between
the toes.